Despite tremendous recent advances in HIV care, morbidity and mortality related to HIV/AIDS in the developing world remain unacceptably high. A major contributing factor is that in developing countries over 800 million people are chronically undernourished and the epidemics of hunger and HIV overlap. As HIV infection progresses, it causes a catabolic state which is compounded by lack of caloric intake and increased susceptibility to infection, leading to worsening malnutrition. Food insecurity involves competing choices between food and healthcare that risks compromising adherence to HIV treatment. The World Health Organization, the Joint United Nations Program on HIV/AIDS and the World Bank have all recently emphasized that nutrition interventions should be systematically linked to antiretroviral therapy programs. Despite this, data are lacking on how to effectively implement nutrition programs in the context of HIV care;on whether food assistance results in clinical or nutritional benefits for those with HIV infection or their household members. Our research group comprises experts in the fields of HIV care and programmatic research in resource-poor settings partnered with experts in nutrition, economic development and food security as well as international HIV policy. This group is in a unique position to fulfill the following four specific aims: 1) To develop a tailored food basket coupled with an educational intervention for individuals with HIV infection and their households in rural Haiti;2) To develop a cohort of 500 households in rural Haiti, each with at least one member with HIV infection, and follow them for 36 months, collecting data on demographics, HIV disease progression, quality of life, nutritional status, food security, and household economic indicators;3) To determine the impact of 12 months of the tailored food basket linked to an HIV treatment program on the clinical, nutritional and economic outcomes of rural Haitians with HIV infection and their households, compared to similarly-affected households that do not receive such an intervention;4) To evaluate the cost and cost-effectiveness of this intervention. We hypothesize that, compared to individuals with HIV and their households that do not receive such an intervention, a tailored food basket is: i) associated with better clinical outcomes and quality of life in individuals with HIV infection;ii) associated with improved nutritional outcomes in those with HIV infection and their household members;iii) associated with better household food security and economic welfare, and iv) is cost- effective by international standards. By fulfilling the four specific aims, this resubmitted, new investigator R01 study will provide critically needed evidence to optimize the link between HIV programs and nutrition interventions, and fulfills the National Institute of Child Health and Human Development's mission to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation. PUBLIC HEALTH RELEVANCE: By determining the clinical, nutritional and quality of life benefits of a tailored food basket to those with HIV infection and their households, this prospective cohort study with group randomization will contribute critical evidence towards improving the management of two issues of global health urgency: under nutrition and HIV infection. In addition, by determining the cost and cost-effectiveness of the intervention, the study will provide physicians, patients and policymakers with critical data to inform HIV and nutrition programming and policy in developing country settings.